Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis
Primary Purpose
Chronic Periodontitis, Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Ultrasonic debridement
Antimicrobial photodynamic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Photodynamic therapy, Ultrasonic debridement, Chronic periodontitis, Type 2 diabetes
Eligibility Criteria
Inclusion Criteria:
- diagnosis of type 2 DM for ≥5 years
- DM treatment with oral hypoglycemic agents or insulin supplementation and diet
- glycated hemoglobin (HbA1c) levels from 6.5% to 11%
- at least 15 teeth (excluding third molars and teeth indicated for extraction)
- moderate to severe generalized chronic periodontitis (Armitage, 1999)
- agree and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the study (Resolution number 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO179/93).
Exclusion Criteria:
- medical conditions that required prophylactic antimicrobial coverage
- SRP in the previous 6 months
- antimicrobial therapies in the previous 6 months
- anti-inflammatory therapies in the previous 6 months
- systemic conditions, other than DM, that could affect the progression of chronic periodontitis
- current use of medication that could interfere with periodontal response to treatment
- pregnancy or lactation
- smoking
Sites / Locations
- Instituto de Ciência e Tecnologia de São José dos Campos - UNESP
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Ultrasonic Debridement (UD)
UD + Antimicrobial Photodynamic Therapy
Arm Description
Ultrasonic Debridement (UD) (n=20)
Ultrasonic Debridement + aPDT (UD+aPDT) (n=20)
Outcomes
Primary Outcome Measures
Probing Depth
Assessed with manual probe (North Carolina, Hu-Friedy)
Secondary Outcome Measures
Clinical Attachment Level
Assessed with manual probe (North Carolina, Hu-Friedy)
Full Information
NCT ID
NCT02627534
First Posted
November 25, 2015
Last Updated
December 10, 2015
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
1. Study Identification
Unique Protocol Identification Number
NCT02627534
Brief Title
Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis
Official Title
Local Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis: Split-mouth Randomized Triple-blind Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Periodontal Diseases are considered the sixth complication of Diabetes Mellitus (DM). This close relationship between both diseases is characterized by mutual influence. The presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone biology, and the establishment of infections. Consequently, knowledge of new dental therapies and the biology of dental treatments for chronic periodontitis in diabetic patients can enhance quality of life and make these treatments more adequate for this common profile of patients.
Detailed Description
Diabetes mellitus (DM) has become a global epidemic. Its complications can have a significant impact on quality of life, longevity, and costs in public health. The World Health Organization (WHO) estimates that by 2030, 439 million people will suffer from diabetes, around 10% of the world adult population (WHO, 2011). Periodontal Diseases are considered the sixth complication of DM. This close relationship between both diseases is characterized by mutual influence. Thus, an appropriate control of periodontal disease may facilitate the DM control, improving quality of life on diabetes patients. Besides that, the presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone biology, and the establishment of infections. Consequently, knowledge of new dental therapies and the biology of dental treatments for chronic periodontitis in diabetic patients can enhance quality of life and make these treatments more adequate for this common profile of patients. Therefore, the aim of the present study is to investigate the effectiveness of antimicrobial photodynamic therapy as adjunct to full-mouth debridement for the treatment of periodontitis in type 2 diabetic patients through a split-mouth randomized triple-blind clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Diabetes Mellitus
Keywords
Photodynamic therapy, Ultrasonic debridement, Chronic periodontitis, Type 2 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasonic Debridement (UD)
Arm Type
Active Comparator
Arm Description
Ultrasonic Debridement (UD) (n=20)
Arm Title
UD + Antimicrobial Photodynamic Therapy
Arm Type
Experimental
Arm Description
Ultrasonic Debridement + aPDT (UD+aPDT) (n=20)
Intervention Type
Procedure
Intervention Name(s)
Ultrasonic debridement
Intervention Description
All periodontal pockets received ultrasonic debridement (Cavitron, Dentsply) with specific inserts (UI25KSF10S, Hu-Friedy). All diseased sites were instrumented in one session by an experienced periodontist.
Intervention Type
Procedure
Intervention Name(s)
Antimicrobial photodynamic therapy
Intervention Description
After ultrasonic debridement, one randomly selected periodontal pocket received an additional aPDT performed by a trained operator (NMRBA). One pocket with probing depth ≥ 5mm in each patient was randomly selected to aPDT. After washing the pocket with saline solution, the photosensitizer (methylene blue 10mg/ml) was applied to the bottom of the pocket in a coronal direction. Following this, the pocket was exposed to a diode laser light with a fibre optic application for 1 min (Thera Lase DMC - Brazil), with wavelength of 660nm, power of 60mW and fluency of 129J/cm2.
Primary Outcome Measure Information:
Title
Probing Depth
Description
Assessed with manual probe (North Carolina, Hu-Friedy)
Time Frame
Reductions in Probing Depth was compared at baseline and 180 days
Secondary Outcome Measure Information:
Title
Clinical Attachment Level
Description
Assessed with manual probe (North Carolina, Hu-Friedy)
Time Frame
Clinical Attachment Level gain was compared at baseline and 180 days
Other Pre-specified Outcome Measures:
Title
Gingival Recession
Description
Assessed with manual probe (North Carolina, Hu-Friedy)
Time Frame
Gingival Recession changes was compared at baseline and 180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of type 2 DM for ≥5 years
DM treatment with oral hypoglycemic agents or insulin supplementation and diet
glycated hemoglobin (HbA1c) levels from 6.5% to 11%
at least 15 teeth (excluding third molars and teeth indicated for extraction)
moderate to severe generalized chronic periodontitis (Armitage, 1999)
agree and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the study (Resolution number 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO179/93).
Exclusion Criteria:
medical conditions that required prophylactic antimicrobial coverage
SRP in the previous 6 months
antimicrobial therapies in the previous 6 months
anti-inflammatory therapies in the previous 6 months
systemic conditions, other than DM, that could affect the progression of chronic periodontitis
current use of medication that could interfere with periodontal response to treatment
pregnancy or lactation
smoking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro P Santamaria, PhD
Organizational Affiliation
ICT - UNESP
Official's Role
Study Director
Facility Information:
Facility Name
Instituto de Ciência e Tecnologia de São José dos Campos - UNESP
City
Sâo José dos Campos
State/Province
São Paulo
ZIP/Postal Code
12245-000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
27448223
Citation
Castro Dos Santos NC, Andere NM, Araujo CF, de Marco AC, Dos Santos LM, Jardini MA, Santamaria MP. Local adjunct effect of antimicrobial photodynamic therapy for the treatment of chronic periodontitis in type 2 diabetics: split-mouth double-blind randomized controlled clinical trial. Lasers Med Sci. 2016 Nov;31(8):1633-1640. doi: 10.1007/s10103-016-2030-8. Epub 2016 Jul 22.
Results Reference
derived
Learn more about this trial
Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis
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